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Goal-based safety cases for medical devices: Opportunities and challenges

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Sujan, Mark-Alexander, Koorrmeef, Floor and Voges, Udo (2007) Goal-based safety cases for medical devices: Opportunities and challenges. In: 26th International Conference on Computer Safety, Reliability and Security, Nuremberg, GERMANY, SEP 18-21, 2007. Published in: COMPUTER SAFETY, RELIABILITY, AND SECURITY, PROCEEDINGS, 4680 pp. 14-27.

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Abstract

In virtually all safety-critical industries the operators of systems have to demonstrate a systematic and thorough consideration of safety. This is increasingly being done by demonstrating that certain goals have been achieved, rather than by simply following prescriptive standards. Such goal-based safety cases could be a valuable tool for reasoning about safety in healthcare organisations, such as hospitals. System-wide safety cases are very complex, and a reasonable approach is to break down the safety argument into sub-system safety cases. In this paper we outline the development of a goal-based top-level argument for demonstrating the safety of a particular class of medical devices (medical beds). We review relevant standards both from healthcare and from other industries, and illustrate how these can inform the development of an appropriate safety argument. Finally, we discuss opportunities and challenges for the development and use of goal-based safety cases in healthcare.

Item Type: Conference Item (UNSPECIFIED)
Subjects: Q Science > QA Mathematics > QA76 Electronic computers. Computer science. Computer software
Series Name: LECTURE NOTES IN COMPUTER SCIENCE
Journal or Publication Title: COMPUTER SAFETY, RELIABILITY, AND SECURITY, PROCEEDINGS
Publisher: SPRINGER-VERLAG BERLIN
ISBN: 978-3-540-75100-7
ISSN: 0302-9743
Editor: Saglietti, F and Oster, N
Date: 2007
Volume: 4680
Number of Pages: 14
Page Range: pp. 14-27
Publication Status: Published
Title of Event: 26th International Conference on Computer Safety, Reliability and Security
Location of Event: Nuremberg, GERMANY
Date(s) of Event: SEP 18-21, 2007
URI: http://wrap.warwick.ac.uk/id/eprint/30912

Data sourced from Thomson Reuters' Web of Knowledge

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